Efficacy of Cholesterol-lowering L. Plantarum on Cardiometabolic Health Biomarkers in Coeliac Disease Patients

NCT06178107 | Active Not Recruiting

• 1 other identifier: LSC 23/ 395
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 2

Brief Summary

Recent studies have also shown that 30% of the world's population carries the susceptibility genes for coeliac disease and that only 2-5% of these individuals are really affected, however, studies suggest the existence of other factors capable of contributing to the onset of the disease, such as intestinal dysbiosis. We have also seen how each of us has a specific microbiota, defined as an individual human enterotype, which depends on our background and can be modified by the diet. Recently, much interest has been directed to a strain of lactobacilli, called Lactobacillus plantarum (LP-LDL®) capable of reducing cholesterol and preventing the reabsorption of bile salts in the liver. The efficacy of this bacterial strain has been confirmed in 3 different human studies demonstrating the efficacy of LP-LDL® in patients with high baseline cholesterol (TC\> 6mmol / L). This is a food supplement that has been commercially available in multiple formulations in Europe for over 3 years. LP-LDP is a probiotic strain, safe to use, selected for its high bile salt hydrolase in vitro, and in vivo cholesterol reduction activity. The intake of 2 Å\~ 109 CFU encapsulated LP-LDL twice daily, significantly reduced LDL-C (13.9%), total cholesterol (TC) (37.6%), TG (53.9%), and significantly increased HDL-C (14.7%; in subjects \>60 years of age; 6-12 weeks) in normal to mildly hypercholesterolaemic subjects. In a recent double-blind placebo-controlled human study published by the Journal of Functional Foods (2022) and carried out by the University of Roehampton (UK), LPLDL showcased statistically significant reductions in multiple cardiovascular risk biomarkers, including total cholesterol, LDL cholesterol, non-HDL cholesterol and apoB. No adverse effects were noted throughout the study. We are here proposing a pilot human intervention study to evaluate the effectiveness of the LP-LDL® probiotic in reducing cardiovascular risk factors inclusive of cholesterol in the blood in people with coeliac disease.

Conditions

Celiac Disease

Keywords

PROBIOTICS, HIGH CHOLESTEROLEMIA

Outcome Measures

Primary Outcomes (2)

• Change in blood cholesterol levels

  To test, in humans, whether LPLDL® intervention lowers total cholesterol compared to the baseline levels

  Change from baseline to 6 and 9 weeks of the intervention

• Change in BMI (body mass index) Scores

  To test wheter LPLDL® intervention affect body mass indes in kg/m\^2

  Change from baseline to 6 and 9 weeks of the intervention

Secondary Outcomes (4)

• Change in the gut microbiota diversity

  Change from baseline to 6 and 9 weeks of the intervention

• Change in dietary habits

  Change from baseline to 6 and 9 weeks of the intervention

• Change in VitD levels

  Change from baseline to 6 and 9 weeks of the intervention

• Change in ApoB concentration

  Change from baseline to 6 and 9 weeks of the intervention

Study Arms (2)

Probiotic

EXPERIMENTAL

Lactobacillus plantarum (LPLDL®) equivalent to 4 x10\^9 CFU (0.1 g) with the addition of filling carrier (0.12 g; 30% w/v maltodextrin and 5% w/v sucrose) as a capsular format (vegetable) to be consumed once a day, after lunch with 250mL of water.

Dietary Supplement: LP-LDL Probiotic

placebo

PLACEBO COMPARATOR

Maltodextrin (an oligosaccharide without prebiotic effect) (0.12 g; 30% w/v maltodextrin and 5% w/v sucrose) as a capsular format (vegetable) to be consumed once a day, after lunch with 250mL of water.

Dietary Supplement: Placebo Comparator

Interventions

LP-LDL Probiotic DIETARY_SUPPLEMENT

LP-LDL a dietary food supplement probiotic

Also known as: Placebo Comparator

Probiotic

Placebo Comparator DIETARY_SUPPLEMENT

Placebo comparator Maltodextrin

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged between 18 and 65 years, with CD Diagnosis
• Fasting blood glucose level not above 5.6-6.9mmol/L
• High baseline cholesterol (TC\> 6mmol / L).
• HbA1c below 5.7%
• With cholesterol
• For intervention purposes, eligible participants are also required to have a mobile phone and be able to read and speak English.

You may not qualify if:

• People with comorbid conditions that may limit participation in the study, such as a history of an acute cardiovascular event, uncontrolled hypertension, cancer or major psychiatric or cognitive problems
• People who are already participating in a weight loss programme
• People receiving drug treatment for lipid metabolisms (e.g., statins
• People with a history of long-term use of medicines known to influence glucose metabolism (e.g., corticosteroids)
• People with elevated liver enzymes (alanine aminotransferase ≥300 IU/L, aspartate aminotransferase ≥300 IU/L)
• People who take antibiotics or bacterial agents (Probiotics) within 1 month
• Pregnant women, women ready for pregnancy, and nursing mothers
• All capsules (probiotic and placebo) have the same taste and appearance and have been mixed, encapsulated and packaged to ensure product consistency throughout the study. All capsules will be distributed free of charge to participants in this study.

Sponsors & Collaborators

• University of Roehampton: lead

Study Sites (2)

Uoc Di Gastroenterologia Aou S. Giovanni Di Dio E Ruggi D'Aragona

Salerno, 84131, Italy

Location

Health Sciences Research Centre, Life Sciences Department, University of Roehampton

London, UK, SW15 4JD, United Kingdom

Location

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Adele Costabile, Prof

  Roehampton University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study PI

Model Details: This is a double blinded, randomised of parallel design pilot study will include 50 adults aged 18-65 with coeliac disease (CD). After an initial screening, potential subjects will be assessed for inclusion in the run-in trial. Those subjects who meet the inclusion criteria will be then invited to the intervention study for a total duration of 9 weeks, followed by 3 weeks follow up.

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: December 20, 2023
• Study Start: April 12, 2022
• Primary Completion: July 30, 2024
• Study Completion: December 21, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); GB (1)